(BBC.com)–The total disc replacement implant made by Cambridge-based Ranier Technology left patients across Europe in agony and needing further surgery after breaking inside their backs.Last month, BBC Panorama revealed how the Cadisc L implant was approved for use in humans despite evidence from studies in baboons that it could fail.
Ranier withdrew it from market in 2014.Geoffrey Andrews, the founder and former CEO of Ranier told Panorama that the company has “scrupulously followed the procedures and standards required by all regulatory authorities”.
The prosecutors in Switzerland are investigating the circumstances in which the device was implanted into patients.
The hospital concerned has already launched a separate investigation.A leading surgeon, Max Aebi, implanted the device into at least seven patients.Mr Aebi was on Ranier’s scientific advisory board and, according to minutes of meetings seen by Panorama, brushed off concerns raised by the animal studies.At a meeting of the board at City Airport in 2009 Mr Aebi described the adverse findings of a review of the baboon study as “just a radiological review” which “does not have anything to do with reality”.
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